• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

  On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

  RulingsRemand decision

  • RemandOther

    “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

  • BurdenNot shown unpatentable

    “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

  Patent outcomesUS 10,760,127 not shown unpatentable
  § 103 obviousness
  Patents in suitUS 10,760,127
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

  Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

  • BurdenNot shown unpatentable

    “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

    “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

  Patent outcomesUS 11,959,109 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

  Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

  Patent outcomesUS 11,236,318 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,236,318
• Resmed Corp. v. Cleveland Medical Devices, Inc.All claims unpatentable
  PTAB · Jun 29, 2026 · IPR2025-00246 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 15–29 are unpatentable as obvious over the asserted combinations; the contingent motion to amend claims 30–41 is denied for lack of written-description support.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, ResMed Inc., as a real party in interest. Paper 39. Petitioner filed an opposition. Paper 42. Patent Owner filed a reply. Paper 43. We denied the Motion to Terminate. Paper 51.” slip op. at 3

  • Skill levelSkill level board ownOther

    “understanding of a person of ordinary skill in the art at the time the invention was made.10 See Graham, 383 U.S. at 17–18. The parties agree that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 3–4 (citing Ex. 1003 (Kirkness Decl.) ¶ 44); PO Resp. 4. 9 Patent Owner does not assert any objective indicia of nonobviousness. See generally PO Resp. 10 For purposes of this Decision, we apply a priority date of November 4, 2005. See supra n.4. Because the proposed level of ordinary skill in the art is consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Patent Owner does not persuade us to construe the term as “a value [or calculated value] that indicates how dire a patient’s symptoms are.” Patent Owner points to nothing in the intrinsic record that purportedly supports this construction, and we agree with Petitioner that “the patent specification’s disclosures regarding determining a level of symptom severity are broad, establishing that it can generally be derived from any sensor data and/or breathing events.” Pet. Reply 3–4; see also Ex. 1001, 3:44–46 (“Signals from the[] sensors are then analyzed to determine the level of severity of the symptoms of the subject’s sleep disorder.”). Patent Owner relies only on expert declarations to support its construction. But as indicated by the Federal Circuit, extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable here, where neither Dr. D’Ambrosio’s nor Dr. Schwartz’s declaration was prepared for this proceeding, and neither declarant was subject to cross examination on their opinions. Moreover, neither of the declarants was opining on claim construction; rather, they were addressing indefiniteness and/or written description issues. See Ex. 1058 at 7 (heading addressing definiteness); Ex. 2026 at 18 (heading addressing written description). Further, Dr. Schwartz appears to have been making an argument about certain patent claims (not the challenged ’333 patent) based on Patent Owner’s own statements made during prosecution of a separate patent application. See Ex. 2026 ¶ 47 (“[T]he similar term used in the ’284 patent claims (‘data of severity of sleep disorder symptoms’) does not find written description support in the specification by a disclosure of the same statistics disclosed in Wright, because CleveMed argued those statistics are not related to severity of sleep disorder symptoms.” (emphasis added)). Patent Owner has not persuaded us that Dr. Schwartz’s testimony has direct applicability to the claim term at issue here. Dr. Borkholder’s testimony is likewise unpersuasive. Aside from citing Dr. D’Ambrosio’s and Dr. Schwartz’s declarations, Dr. Borkholder cites Exhibits 2027 and 2016. These exhibits discuss indices such as AHI and RDI that are used to assess the severity of a patient’s symptoms, but Patent Owner has not adequately explained how they bear on construction of the claim term at issue here, which is not addressed in these exhibits. Ex. 2022 ¶¶ 32–33. Accordingly, we accord Dr. Borkholder’s claim construction opinions little weight, because they are unsupported by reference to objective, corroborating evidence of record. See, e.g., Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations . . . may render the testimony of little probative value in a validity determination.”); Xerox Corp. v. Bytemark, IPR2022-00624, Paper 9, 15 (PTAB 2023) (precedential) (explaining that declaration testimony that “is conclusory and unsupported” and which “adds little to the conclusory assertion for which it is offered to support . . . is entitled to little weight”).” slip op. at 23

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “We find that Petitioner has the better argument. Tidal volume refers to “the volume of air that is inspired or expired during a respiratory cycle.” Ex. 2028, 13–14; PO Resp. 10. “[H]ypopnea events are defined as a reduction of ≥50 % or 74 % in tidal volume from baseline and apnea events as absence of tidal volume for at least 10s.” Ex. 2028, 13–14 (emphasis omitted). Toge teaches that a control unit analyzes collected data (e.g., the flow rate) and calculates tidal volume. Ex. 1044 (Toge) ¶¶ 34–38. The calculated tidal volume is “a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy” because it represents, e.g., the “level of airway obstruction the patient experiences during the sleep apnea treatment using the PAP device.” Pet. 15. As Dr. Chatterjee explains: Toge discloses that tidal volume Fp is a quantified level of data because Toge discloses that Fp is monitored with respect to threshold values (id., [0051]) and because Fp is a function of Ft, Fa, and Fb, which are quantitative values. Toge discloses that tidal volume Fp is severity data because Toge discloses that tidal volume is indicative of whether the patient’s breathing warrants “emergency measures” (id., [0039]) and whether to “send an alert” in “an emergency where the patient’s breathing has drastically weakened” (id., [0055]). . . . . Because Toge discloses determining tidal volume (determine a quantified level of severity data) based on Ft, Fa, and Fb (id., [0035]), which corresponds to the subject’s condition (subject’s sleep apnea symptoms) while using the device (during the therapy) (id., [0036], [0037]), Toge discloses determin[ing] a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy. Ex. 1005 (Chatterjee Decl.) ¶¶ 122–125. Patent Owner’s attempt to dismiss tidal volume as a mere “breathing metric” is unavailing. First, Petitioner correctly “notes that in the paragraph PO cites to in Dr. Schwartz’s declaration, he indicates that breathing metrics are a level of severity data.” Pet. Reply 8 (citing Ex. 2026 ¶ 46 (“standard sleep disordered breathing metrics” [ ] were well validated indicators of the type and severity of sleep disordered breathing”)). Second, Dr. Kirkness explains that tidal volume represents the level of airway obstruction, e.g., apnea “is the most severe form of reduction in airflow [and] the absence of airflow results in quantified tidal volume of zero milliliters per breath.” Ex. 1003 (Kirkness Decl.) ¶¶ 157, 159; see also PO Resp. 10–11 (Patent Owner recognizing that an apnea is defined as absence of tidal volume for at least 10 seconds). The calculated tidal volume thus indicates severity because it is used to adjust the PAP system, e.g., in the case of decreasing tidal volume, a medical professional can change the airflow settings “to counter/treat the more severe level of airway obstruction observed from the decreasing tidal volume.” Ex. 1003 (Kirkness Decl.) ¶ 158; Pet. 15–16; Ex. 1044 (Toge) ¶ 39.” slip op. at 26

  Patent outcomesUS 11,857,333 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,857,333
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · Jun 5, 2026 · IPR2025-00160 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–5, 7, 8, 10–13, 15–18, and 20–31 were not shown unpatentable because the proposed Toge-Kumar combination did not establish the claimed remote internet site hosted on a server.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Patent Owner filed a Response. Paper 23 (“PO Resp.”). Petitioner filed a Reply. Paper 27 (“Reply”). Patent Owner filed a Sur-reply. Paper 35 (“Sur-reply”). Additionally, during trial, Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name a real party in interest (namely, Petitioner’s corporate parent, Resmed Inc.). Paper 37. Petitioner filed an opposition. Paper 38. Patent Owner filed a reply. Paper 39. We denied the Motion to Terminate. Paper 44.” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability. C. Level of Ordinary Skill in the Art” slip op. at 11

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s proposed level of ordinary skill in the art because it appears to be consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level). D. Summary of the Asserted Prior Art” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “summarized above, we determine that a person of ordinary skill in the art would not have implemented Toge’s physician-side computer as a web server using a “localhost” architecture as proposed by Petitioner because such a configuration cannot communicate with external devices over the public internet, a deficiency that directly contradicts Petitioner’s stated motivations for the combination of permitting broad data access. Petitioner’s expert, Dr. Chatterjee, expressly acknowledged in his Reply Declaration that when a client and server reside on the same machine, the communications between them do not traverse the internet. Ex. 1069 ¶ 8. Specifically, Dr. Chatterjee cited the Microsoft Computer Dictionary’s definition of “localhost” as “[t]he name that is used to represent the same computer on which a TCP/IP message originates,” noting that “[a]n IP packet sent to localhost has the IP address 127.0.0.1 and does not actually go out to the Internet.” Id. (citing Ex. 1070, 316). Accordingly, Petitioner’s proposed configuration of placing both the client and web server on Toge’s physician-side computer would create a closed loop of communication that does not reach the broader network. Id. As noted by Patent Owner, “[i]f ‘the physician-side computer and the web server are on one machine,’ the local web server would not communicate with other devices via the Internet.” Sur-Reply, 3–4 (comparing Ex. 1069 ¶ 19 with id. at ¶ 8). Thus, the consequence of Petitioner’s proposed Toge-Kumar configuration is that other devices in the system, such as the PAP device that generates the treatment data and any remote client devices that might need to access that data, would be unable to send data to or retrieve data from the localhost web server. Patent Owner persuasively argues, supported by evidence of record, that under Petitioner’s proposed configuration, “the PAP device could not send data thereto nor could other clients receive data therefrom, as only the local client browser can exchange data.” Id. (citing Ex. 1069 ¶ 8); see Ex. 2003, 4 (one-tier architecture “is not suitable for a web application” because “it can only access data available in a single computer or server” and therefore “is not suitable for a web application.”); Ex. 2022, 3 (Unlike more advanced multi-tier systems, a one-tier architecture “cannot transmit information from one client machine to another.”); Ex. 2020, 4 (While “the client process and server process can be on the same computer,” this architecture “is rarely used today” precisely because it cannot “take advantage of the distributed computing environment.”).” slip op. at 29

  Patent outcomesUS 11,786,680 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,786,680
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · Jun 4, 2026 · IPR2025-00158 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–20 were not shown unpatentable because Orbach did not disclose a single computer or processor performing all claimed remote analysis, output, and display functions.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “After considering all of the arguments and evidence presented on the full trial record, we determine that Petitioner has not demonstrated by a preponderance of the evidence that claims 1–6, 8–17, 19, and 20 are unpatentable as obvious over the combination of Ciulla and Orbach. We find that the deficiencies in Petitioner’s arguments regarding claim limitations [1.d], [1.f], and [1.g] are dispositive and we address the parties’ arguments concerning those limitations below.” slip op. at 24

  • Skill levelSkill level petitioner adoptedOther

    “Pet. 8. Patent Owner agrees to apply Petitioner’s proposed definition of POSITA. PO Resp. 4. We adopt Petitioner’s proposed definition of a POSITA because the proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “the Board need not construe any terms. Pet. 9. Patent Owner agrees. PO Resp. 4. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Nevertheless, in our analysis of the asserted grounds of unpatentability below, we discuss the scope of certain claim terms, e.g., “the computer” and “the processor.” C. Level of Ordinary Skill in the Art” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “Accordingly, to show obviousness, Petitioner must show in Orbach that either (a) remote server 140’s output to viewing station 150 constitutes “display” within the meaning of the claim, or (b) viewing station 150 receives data “over cell towers” notwithstanding the intervening server. We determine that Petitioner has failed to do so on this record. Our analysis follows.” slip op. at 33

  Patent outcomesUS 11,690,512 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,690,512
• Resmed Corp. v. Cleveland Medical Devices, Inc.No claims unpatentable
  PTAB · May 18, 2026 · IPR2025-00159 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1, 2, 4, 5, 7–9, 11–14, and 16 were not shown unpatentable under either § 103 ground because Petitioner did not establish the proposed remote internet site modification.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for patent ownerDecided for patent owner

    “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name a real party in interest (namely, Petitioner’s corporate parent, Resmed Inc.). Paper 37. Petitioner filed an opposition. Paper 38. Patent Owner filed a reply. Paper 39. We denied the Motion to Terminate. Paper 44.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art at the time the invention was made.8 See Graham, 383 U.S. at 17–18. The parties agree that a person of ordinary skill in the art (sometimes referred to herein as a POSITA) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 12–13 (citing Ex. 1003 (Kirkness Decl.) ¶¶ 44–46); PO Resp. 7–8. Because the proposed level of ordinary skill in the art is consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We find it unnecessary to construe any claim term to resolve the issues in this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “its burden of explaining why a person of ordinary skill in the art would have implemented a remote internet site in Toge’s system in the specific fashion Petitioner asserts (i.e., using the physician-side computer as a web server). As Patent Owner aptly states, the operative question is not merely whether a person of ordinary skill in the art would have modified Toge’s system to include a remote internet site, but whether the artisan would have modified Toge’s system to include a remote internet site “on a physician’s client computer” in accordance with the specific implementation argued by Petitioner. Sur-reply 2. On this critical question, Petitioner’s arguments are thin. Petitioner’s declarant Dr. Kirkness states that a person of ordinary skill in the art “would have understood that one common way to access data transmitted over the internet, like the data from Toge’s wireless PAP device, is via a remote internet site.” Ex. 1003 ¶ 214. This assertion is reasonable. Indeed, prior art of record, such as Kumar, illustrates use of a central server that hosts a browser-based engine that can be accessed through web pages. See, e.g., Ex. 1008 (Kumar) Fig. 1A, ¶¶ 67, 72, 79, Pet. 10. Petitioner, however, elected to argue a specific implementation, namely that the skilled artisan would have modified Toge’s physician-side computer to operate as a web server. See, e.g., Pet. 15; Ex. 1005 (Chatterjee Decl.) ¶ 146; Reply 4. We find that this implementation is unsupported on this record. Petitioner has not pointed us to any disclosure in Toge, Burton, or Kumar (or any other prior art reference of record) that teaches or suggests “that a doctor’s computer should act a web server hosting sensitive patient data.” PO Resp. 9 (emphasis added). And critically, the Petition is silent as to why a person of ordinary skill in the art would have selected this implementation in particular. See, e.g., Pet. 49.” slip op. at 25

  Patent outcomesUS 11,375,921 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,375,921
• Stryker Corporation / Wright Medical Technology, Inc v. Osteomed LLCAll claims unpatentable
  PTAB · May 4, 2026 · IPR2022-00191 · APJ Sheridan K Snedden · IPR · Remand

  On remand, the Board held claims 15 and 21 unpatentable as anticipated by Slater.

  RulingsRemand decision

  • RemandOther

    “Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 381), affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 35) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1, 10, and 16 of U.S. Patent No. 9,763,716 B2 (“the ’716 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether either of dependent claims 15 and 21 is unpatentable. Stryker, slip op. at 17.” slip op. at 2

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “We have reviewed Petitioner’s arguments and evidence as to the undisputed limitations of claims 15 and 21 and find that Petitioner establishes that Slater discloses each limitation of claims 15 and 21 for the reasons provided by Petitioner. Specifically, Petitioner shows, and Patent Owner does not dispute, that Slater describes a plate with “flared hips” comprising opposing “generally parabolic wings” as recited in dependent claims 15 and 21. Pet. 31–33; Ex. 1005, Fig. 2; Ex. 1002 ¶ 124. We adopt Petitioner’s arguments and evidence as to these limitations as our own. See Pet. 31–33. Based on the foregoing, Petitioner proves by a preponderance of the evidence that Slater anticipates claims 15 and 21.” slip op. at 13

  Patent outcomesUS 9,763,716 unpatentable
  § 102 anticipation
  Patents in suitUS 9,763,716
• Stryker Corporation / Wright Medical Technology, Inc. v. Osteomed LLCSome claims unpatentable
  PTAB · May 4, 2026 · IPR2021-01451 · APJ Sheridan K Snedden · IPR · Remand

  On remand, claims 6, 8, 9, and 13 were held unpatentable; claims 2–5, 11, and 12 were not shown unpatentable because Slater lacks the claimed central axis.

  RulingsRemand decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed

    “addressing the ’085 patent and by the court’s analysis in Stryker, we conclude that Slater does not anticipate claims 2–5, 11, and 12 of the ’776 patent because Slater deliberately describes a variable angle hole that lacks a single predetermined angle—that is, Slater describes a transfixation screw hole that does not have a central axis defining the trajectory.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “In its Petition, Petitioner contends that Weaver discloses the limitations in claim 6 and that it would have been obvious to add Weaver’s features to Slater’s plate to provide a more secure fixation between the screws and the plate. Pet. 36–39; Ex. 1002 ¶¶ 169–74. Specifically, Petitioner contends that configuring Slater’s transfixation screw hole (claim 6) or at least one of Slater’s attachment points (claim 8) as a threaded screw hole to lockably engage the head of a locking screw would have been an obvious design choice “because locking screws ‘provide a high resistance to shear or torsional forces’ and reduce the incidence of screw loosening.” Pet. 39 (quoting Ex. 1009, 1:57–58); Ex. 1009, 1:46–48; Ex. 1002 ¶¶ 169– 74. Petitioner otherwise relies on its anticipation analysis for claim 1 discussed above. Pet. 36.” slip op. at 17

  • RemandOther

    “Appeals for the Federal Circuit. The court issued its decision in Stryker Corp. v. OsteoMed LLC, No. 2023-1925, 2025 WL 2814019 (Fed. Cir. Oct. 3, 2025) (“Stryker”) (Paper 49),1 affirming-in-part, reversing-in-part, vacating and remanding-in-part our Final Written Decision (Paper 46, “FWD”) for further proceedings. In its opinion, the Federal Circuit reversed our finding of no anticipation as to independent claims 1 and 10 of U.S. Patent 9,351,776 B2 (“the ’776 patent,” Ex. 1001), and vacated and remanded for further proceedings to evaluate whether dependent claims 2–6 and 8, 9 and 11–13 (the “Remanded Claims”) are unpatentable in view of Petitioner’s challenges relying on the Slater reference. Stryker, slip op. 14– 15.” slip op. at 2

  Patent outcomesUS 9,351,776 mixed
  § 102 anticipation§ 103 obviousness
  Patents in suitUS 9,351,776
• Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentable
  PTAB · Mar 10, 2026 · IPR2024-01209 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–27 are unpatentable as obvious over the asserted combinations, principally Racz, Fitz, and Lee; both parties’ motions to exclude are dismissed as moot.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “PO Resp. 30 (citing Ex. 2006 ¶ 58). Patent Owner’s proposal is too narrow in two respects. First, it mandates certain education and experience in RF neurotomy specifically. This is too narrow as the description of the scope of the invention set forth in the ’782 patent as described above is not limited to RF neurotomy. Second, it requires the POSA to be both a physician who performs thermal ablation (RF neurotomy specifically) and an engineer with training and experience “in the design and development of devices and methods” for performing the same. Id. This is too narrow because it excludes physicians and other advanced degree holders who research and design devices and methods for performing thermal ablation but do not actually operate on patients. We adopt the Petitioner’s definition of a POSA, quoted above, as it is reflective of the level of skill in the art when viewed in light of the disclosure of the ’782 patent. Supra (quoting Pet. 11).” slip op. at 16

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 12 (citing Ex. 1031 ¶106 (Dr. Robert D. Tucker’s11 testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 12. We likewise find no need to do so now, as neither party has proposed a construction for any claim term and none of the parties’ arguments turns on a disputed meaning of any claim language.” slip op. at 11

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “(Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Clay, 966 F.2d at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 34. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 18.” slip op. at 24

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 148 of his declaration. Ex. 1031 ¶148. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶110–117 (Racz), ¶¶118–123 (Fitz), ¶¶124–131 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶132–147). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he has “been a Professor at the University of Iowa where [he] direct[s] an active research program in radiofrequency electrosurgical procedures and instrumentation.” Ex. 1031 ¶3. He has a Ph.D. in biophysics, and he is also a medical doctor (albeit he is not Board certified as pointed out by Patent Owner19). Id. ¶2. He also has additional training and experience that is relevant, but which is not necessary, but further establishes that he is well qualified to offer the opinions set forth in his declaration. Id. ¶¶2–11. Patent Owner argues that Dr. Tucker is not qualified to testify here because “he is not Board certified” and he is “not a pain-specialist physician and has never performed a neurotomy.” PO Resp. 30. Dr. Tucker explained, however, that he is not Board certified nor does he operate on 19 See PO Resp. 30 (citing Ex. 2020, 10:19–12:20). patients because his work focuses on the development of instrumentation, not the use of it, explaining on cross-examination:” slip op. at 39

  Patent outcomesUS 10,966,782 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,966,782

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.